The Recall Desk
ModerateFDA (Drugs)·D-1875-2019·Announced 2019-09-18

AVKARE Fexofenadine Hydrochloride Tablets Recalled for Failed Stability Specifications

AVKARE Inc. is recalling Fexofenadine Hydrochloride Tablets USP 180 mg because the product failed stability specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

AVKARE Inc. is voluntarily recalling 5,953 bottles of Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50. The recall is being conducted because the product failed stability specifications.

The affected product was distributed nationwide in the U.S. The specific lot numbers involved are 067180011A, 067180012A (Expiration 04/2021), and 06718027B1 (Expiration 09/2021).

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The U.S. Food and Drug Administration has classified this recall as Class II.

The recalled product

Product
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Manufacturer
AVKARE Inc.
Category
Drug — Antihistamine
Hazard
Affected units
5,953

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #s: 067180011A
  • 067180012A
  • Exp. 04/2021
  • 06718027B1 Exp. 09/2021

Distribution

Distributed nationwide across the United States.

Related recalls

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Same hazard · failed stability specifications

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